Codonics Medical Printer (NP-1600M,NP1600MD)
FDA 510(k) K962364 · Codonics, Inc.
510(k) numberK962364
Submission
- Device name
- Codonics Medical Printer (NP-1600M,NP1600MD)
- Applicant
- Codonics, Inc.
Middleburg Heights, OH, US - Received
- June 19, 1996
- Decision date
- November 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K021054 | Codonics Horizon Ci Medical Multimedia Dry Imager; Codonics Horizon GS Medical…LMC · Traditional | 05/09/2002SE |
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Questions and answers
When was Codonics Medical Printer (NP-1600M,NP1600MD) cleared by the FDA?
Codonics Medical Printer (NP-1600M,NP1600MD) (K962364) received a 510(k) decision of Substantially Equivalent on November 8, 1996, 142 days after the submission was received.
What is the product code of K962364?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.